Trial Outcomes & Findings for Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder (NCT NCT04830215)

Last Updated: 2024-02-02

Results Overview

The IDS-SR-10 engagement consist of selected 10 item scores, including the following 10 items (clinician-selected): item 8 - Response of your mood to good or desired events, item 15 - Concentration/decision making, item 16 - View of myself, item 17 - View of my future, item 19 - General interest, item 20 - Energy level, item 21 - Capacity for pleasure or enjoyment (excluding sex), item 22 - Interest in sex (interest rated, not activity), item 23 - Feeling slowed down, and item 29- Interpersonal sensitivity. All the 10 items are rated on a 0 (best) to 3 (worst) scale. IDS-SR-10 engagement total score ranges from 0 (best) to 30 (worst). A negative change from baseline indicated improvement. Least square (LS) mean was calculated using a mixed model repeated measure (MMRM) analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

122 participants

Primary outcome timeframe

Baseline to Week 8

Results posted on

2024-02-02

Participant Flow

Participants took part in this study at 15 investigative sites in Canada from 01 April 2021 to 27 May 2022.

A total of 157 participants were screened of which 122 participants were enrolled and 120 participants were treated in the study.

Participant milestones

Participant milestones
Measure	Brexpiprazole Participants received brexpiprazole as a flexible dose; 0.5 milligrams (mg) to 2 mg, orally (PO), once daily (QD), and continued on the stable dose of antidepressant therapy (ADT) up to 8 weeks.
Overall Study STARTED	122
Overall Study Efficacy Analysis Set	120
Overall Study Safety Analysis Set	120
Overall Study COMPLETED	111
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Brexpiprazole Participants received brexpiprazole as a flexible dose; 0.5 milligrams (mg) to 2 mg, orally (PO), once daily (QD), and continued on the stable dose of antidepressant therapy (ADT) up to 8 weeks.
Overall Study Adverse Event	6
Overall Study Failure to Meet Continuation Criteria	1
Overall Study Withdrawal by Subject	3
Overall Study Protocol Deviation	1

Baseline Characteristics

Efficacy Analysis Set included all participants who had a baseline value and at least one post-baseline efficacy evaluation for IDS-SR total score and IDS-SR-10 engagement during the open label treatment phase. IDS-SR-10-engagement consist of selected 10 item scores, including the following 10 items (clinician-selected): items 8, 15, 16, 17, 19, 20, 21, 22, 23, and 29. All 10 items are rated on a 0 (best) to 3 (worst) scale. The total score ranges from 0 (best) to 30 (worst).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brexpiprazole n=122 Participants Participants received brexpiprazole as a flexible dose; 0.5 mg to 2 mg, PO, QD, and continued on the stable dose of ADT up to 8 weeks.
Age, Continuous	43.0 years STANDARD_DEVIATION 13.1 • n=122 Participants
Sex: Female, Male Female	79 Participants n=122 Participants
Sex: Female, Male Male	43 Participants n=122 Participants
Race/Ethnicity, Customized Race · White	111 Participants n=122 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=122 Participants
Race/Ethnicity, Customized Race · Asian	7 Participants n=122 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=122 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	1 Participants n=122 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	117 Participants n=122 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	3 Participants n=122 Participants
Race/Ethnicity, Customized Ethnicity · Other	1 Participants n=122 Participants
IDS-SR-10 Engagement	16.1 score on a scale STANDARD_DEVIATION 4.7 • n=120 Participants • Efficacy Analysis Set included all participants who had a baseline value and at least one post-baseline efficacy evaluation for IDS-SR total score and IDS-SR-10 engagement during the open label treatment phase. IDS-SR-10-engagement consist of selected 10 item scores, including the following 10 items (clinician-selected): items 8, 15, 16, 17, 19, 20, 21, 22, 23, and 29. All 10 items are rated on a 0 (best) to 3 (worst) scale. The total score ranges from 0 (best) to 30 (worst).
IDS-SR Total Score	41.3 score on a scale STANDARD_DEVIATION 9.8 • n=120 Participants • Efficacy Analysis Set. IDS-SR is 30-item self-report measure used to assess core diagnostic depressive symptoms \& atypical \& melancholic symptom features of major depressive disorder(MDD).Each item rated=0(best)-3(worst).It is sum of ratings of 28 items. Total score=0(best)-84(worst).Item 9 has 2 subitems 9A (score=1,2,\&3)\& 9B (score=0 or 1).Scores for 9A \& 9B are not included in calculation of total score.Item 11/12 should be completed but not both, item 13/14 should be completed but not both.

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: The Efficacy Analysis Set included all participants who had a baseline value and at least one post-baseline efficacy evaluation for IDS-SR total score and IDS-SR-10-engagement during the open label treatment phase. Overall number analyzed is the number of participants with data available for analysis.

Outcome measures

Outcome measures
Measure	Brexpiprazole n=105 Participants Participants received brexpiprazole as a flexible dose; 0.5 mg to 2 mg, PO, QD, and continued on the stable dose of ADT up to 8 weeks.
Change From Baseline in IDS-SR-10 Engagement	-8.11 score on a scale Standard Error 0.62

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: The Efficacy Analysis included all participants who had a baseline value and at least one post-baseline efficacy evaluation for IDS-SR total score and IDS-SR-10-engagement during the open label treatment phase. Overall number analyzed is the number of participants with data available for analysis.

The IDS-SR is a 30-item self-report measure that was used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorder (MDD). Each item on the IDS-SR scale was rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. IDS-SR total score is the sum of ratings of 28 item scores with the total score ranging from 0 (best) to 84 (worst). Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. A negative change from baseline indicated improvement. LS mean was calculated using a MMRM analysis.

Outcome measures

Outcome measures
Measure	Brexpiprazole n=105 Participants Participants received brexpiprazole as a flexible dose; 0.5 mg to 2 mg, PO, QD, and continued on the stable dose of ADT up to 8 weeks.
Change From Baseline in IDS-SR Total Score	-17.38 score on a scale Standard Error 1.36

Adverse Events

Brexpiprazole

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Brexpiprazole n=120 participants at risk Participants received brexpiprazole as a flexible dose; 0.5 mg to 2 mg, PO, QD, and continued on the stable dose of ADT up to 8 weeks.
Gastrointestinal disorders Nausea	7.5% 9/120 • From first dose of study drug up to Week 8 The Safety Analysis Set included all participants who received at least one dose of open-label brexpiprazole.
General disorders Fatigue	10.8% 13/120 • From first dose of study drug up to Week 8 The Safety Analysis Set included all participants who received at least one dose of open-label brexpiprazole.
Investigations Weight increased	5.8% 7/120 • From first dose of study drug up to Week 8 The Safety Analysis Set included all participants who received at least one dose of open-label brexpiprazole.
Nervous system disorders Headache	10.8% 13/120 • From first dose of study drug up to Week 8 The Safety Analysis Set included all participants who received at least one dose of open-label brexpiprazole.
Nervous system disorders Tremor	6.7% 8/120 • From first dose of study drug up to Week 8 The Safety Analysis Set included all participants who received at least one dose of open-label brexpiprazole.
Psychiatric disorders Insomnia	10.0% 12/120 • From first dose of study drug up to Week 8 The Safety Analysis Set included all participants who received at least one dose of open-label brexpiprazole.

Additional Information

Global Clinical Development

Otsuka Pharmaceutical Development & Commercialization, Inc.

Phone: 1-609-524-6788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place